Light Peptide Neurofilament Protein Test Kit (FIA)
by VivaChek Biotech (Hangzhou) Co., Ltd.
Ref VID156-07-011Model VID156
Active
CE IVDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-VID156F8 D-VID156F8 | Date1 Nov 2023 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDD Active
Specification
- Model / Reference
- VID156, VID156-07-011
- Primary DI / UDI-DI
- D-VID156F8
- Basic UDI-DI
- B-VID156F8
- EMDN Code
- W0102060599 Neoendocrine function assays - other
- Device Class
- Class IVD General
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- CN-MF-000012160
- Authorised representative
- Lotus NL B.V. NL-AR-000000121
Other devices from Vivachek Biotech (Hangzhou) Co., Ltd.
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Properties
Other properties (7)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No